Status:
COMPLETED
The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Low Back Pain.
Lead Sponsor:
Purdue Pharma LP
Conditions:
Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate re...
Detailed Description
Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the rel...
Eligibility Criteria
Inclusion
- unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking \</=2 short-acting opioid doses per day.
- taking \>/=3 opioid doses per day with or without acceptable pain control.
Exclusion
- receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid.
- scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period.
- Other protocol-specific exclusion/inclusion criteria may apply.
Key Trial Info
Start Date :
April 1 1997
Trial Type :
INTERVENTIONAL
End Date :
January 1 1998
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT00315874
Start Date
April 1 1997
End Date
January 1 1998
Last Update
May 14 2013
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Hawthorne & York, Intl, Ltd
Phoenix, Arizona, United States, 85008
2
Arizona Research & Education
Phoenix, Arizona, United States, 85012
3
Gainesville Clinical Research Center
Gainesville, Florida, United States, 32605
4
Park Place Therapeutic Center
Plantation, Florida, United States, 33324